About The Role

Provide quality support for ICU Medical Hardware and Consumable development. The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance with ICU Medical quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards.

Essential Duties & Responsibilities

Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.
Assures conformance with regulations of the FDA and other international regulatory agencies.
Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system.
Ensure all Quality attributes for design changes are met.
Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
Support any potential internal and/or external audits and inspections.
Maintain Design History Files (DHF) up to date as needed.
Effectively interact with cross-functional team members.
Provide quality support and for on-market product issues. Bring issues to closure and escalating to management for support as necessary.
Work special projects as assigned

Knowledge & Skills

Knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
Knowledge of medical device standards, ISO 13485, MDSAP, EU MDR and ISO 14971.
Knowledge in Statistics (Tolerance limits, Cpk, etc.) and Minitab is preferred.

Minimum Qualifications, Education & Experience

Must be at least 18 years of age
Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical) or related field in engineering from an accredited college or university is required.
Minimum of 4 years of experience in R&D and/or Quality is required.
ASQ CQE certification preferred or ability to obtain within one year.

Work Environment

This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
Typically requires travel less than 5-10% of the time